Letters of intent are due February 13, 2009. Full applications are due March 13, 2009.

US$5 million are available in fiscal year 2010 for this Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP-HTM) (U19).

Executive SummaryPurpose. The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) invite applications from single institutions and consortia of institutions to participate in this Funding Opportunity Announcement (FOA), Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP-HTM). The purpose of this FOA is to support integrated and iterative multi-project, multi-disciplinary preclinical and exploratory clinical studies with the goal of advancing safe, novel topical microbicides and microbicide combination strategies for the prevention of sexual transmission of HIV. A minimum of two research projects and an Administrative Core must be proposed. At least one component (research project or scientific core) must be a private sector profit or not-for-profit small, domestic or foreign, pharmaceutical, chemical, bioengineering or biotechnological company. A Scientific Advisory Panel (SAP) for each award under this FOA will be constituted post award but no later than 12 months after award.Mechanism of Support. This FOA will utilize the multi-project Cooperative Agreement (U19) grant mechanism.Funds Available and Anticipated Number of Awards. NIAID and NIMH anticipate awarding a total of $5.0 million in FY 2010. NIMH and NIAID will contribute $0.5 million and $4.5 million to the IPCP-HTM respectively. Two to three new awards are anticipated in response to this RFA.Budget and Project Period. An applicant may request a project period of up to 4 years for an application that does not include a pre-Phase 1 clinical trial, and up to 5 years for an application that includes a pre-Phase 1 clinical trial. Budget requests may not exceed the stated upper limits for each of the categories listed. The total annual direct costs for current IPCP–HTM awards with the following activities range from: (1) $0.5 million to $0.9 million for basic and preclinical research; (2) $0.9 million to $1.2 million for basic and preclinical research that involves non-human primate studies designed to assess the efficacy or safety of a microbicide candidate or strategy; and (3) $1.2 million to $1.6 million for awards involving exploratory pre-Phase 1 clinical trials.Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/ organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.Number of Applications. An investigator can be a PI on only one application, but may serve as a Project Leader and/or Scientific Core Leader on one or more other applications, provided there is no scientific overlap with the application submitted by the PI.Resubmissions. Resubmissions (formerly “revisions/amendments") of a previously reviewed IPCP-HTM grant application are permitted in response to this FOA. Resubmission applications must include an Introduction addressing the previous peer review critiques (Summary Statement).Renewal. Renewal applications are not permitted in response to the FOA.Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.Application Materials. See Section IV.1 for application materials.Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

For complete information on this funding opportunity, please consult the NIH website.

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IRMA (International Rectal Microbicide Advocates) is the bottom line in HIV prevention. We work to advance the research and development of safe, effective, acceptable and accessible rectal microbicides - agents that could provide protection against HIV during anal intercourse - for the women, men, and transgender individuals around the world who need options beyond latex.